The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for N!ce For Planmill.
| Device ID | K173410 |
| 510k Number | K173410 |
| Device Name: | N!ce For Planmill |
| Classification | Powder, Porcelain |
| Applicant | Institut Straumann AG Peter Merian-Weg 12 Basel, CH Ch-4002 |
| Contact | Shokoufeh Khodabandeh |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2017-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031747402 | K173410 | 000 |
| 07630031734976 | K173410 | 000 |
| 07630031734969 | K173410 | 000 |
| 07630031734952 | K173410 | 000 |
| 07630031734945 | K173410 | 000 |
| 07630031734938 | K173410 | 000 |
| 07630031770929 | K173410 | 000 |
| 07630031775306 | K173410 | 000 |
| 07630031775290 | K173410 | 000 |
| 07630031734990 | K173410 | 000 |
| 07630031735003 | K173410 | 000 |
| 07630031735102 | K173410 | 000 |
| 07630031735096 | K173410 | 000 |
| 07630031735089 | K173410 | 000 |
| 07630031735065 | K173410 | 000 |
| 07630031735058 | K173410 | 000 |
| 07630031735041 | K173410 | 000 |
| 07630031735034 | K173410 | 000 |
| 07630031735010 | K173410 | 000 |
| 07630031775283 | K173410 | 000 |